Special Combination of BBI608 and Pembrolizumab

Phase 1

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Napabucasin; Drug: Pembrolizumab

• Registration Number: NCT02851004
• Lead Sponsor: Takayuki Yoshino

Brief Summary

the efficacy and safety of BBI608 in combination with pembrolizumab

Detailed Description

This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.The same analysis will be performed for the additional cohort to the Phase II part, consisting of patients with metastatic CMS 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-08-01
• Study Start: 2016-10
• Primary Completion: 2020-02-03
• Status Verified: 2021-08
• Study Completion: 2021-08-23
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BBI608 + Pembrolizumab	Napabucasin	BBI608 and Pembrolizumab
BBI608 + Pembrolizumab	Pembrolizumab	BBI608 and Pembrolizumab

Primary Outcome Measures

Name	Time	Method
ORR	1 year	Objective response rate determined by RECIST version 1.1: for additional cohort to the Phase II part
irORR	2 years	Immune-related objective response rate determined by their Response Evaluation Criteria In Solid Tumors (RESIST): for the Phase II part

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	4 years	Incidence of adverse events
Pharmacokinetic	2 months	CmaxPeak Plasma Concentration (Cmax)
ORR	2 years	Objective response rate determined by RECIST version 1.1: for the Phase II part
irORR	1 year	Immune-related objective response rate determined by their Response Evaluation Criteria In Solid Tumors (RESIST): for additional cohort to the Phase II part
irPFS	12 weeks	Immune-related progression free survival rate at week 12 determined by the irRECIST
Progression free survival rate at week 12 determined by the RECIST version 1.1	12 weeks	PFS
PFS	3 years	Progression free survival
OS	4 years	Overall survival
DCR	2 years	Disease Control rate

Trial Locations

Locations (1)

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan